CN112292089A - Placement and manufacture of temporarily flexible implantable rods - Google Patents
Placement and manufacture of temporarily flexible implantable rods Download PDFInfo
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- CN112292089A CN112292089A CN201980035135.2A CN201980035135A CN112292089A CN 112292089 A CN112292089 A CN 112292089A CN 201980035135 A CN201980035135 A CN 201980035135A CN 112292089 A CN112292089 A CN 112292089A
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- pedicle screw
- compound
- spinal rod
- rod member
- pedicle
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
- A61B17/7031—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other made wholly or partly of flexible material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7011—Longitudinal element being non-straight, e.g. curved, angled or branched
- A61B17/7013—Longitudinal element being non-straight, e.g. curved, angled or branched the shape of the element being adjustable before use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
Abstract
Disclosed are various embodiments for forming spinal rod members for use in pedicle screw systems in spinal fixation procedures and systems. A system may include a pedicle screw having a pedicle screw head including a hole for receiving and retaining a spinal rod member relative to the pedicle screw and a pedicle screw shaft. Spinal rod members may include an elongated tubular membrane having a flexible body and a spinal rod body formed of a compound by inserting a liquid compound into the elongated tubular membrane and allowing the liquid compound to harden, or by converting the flexible rod into a rigid rod by other similar processes. The pedicle screw head may include a channel configured to receive and retain a spinal rod member.
Description
Cross Reference to Related Applications
This application claims the benefit and priority of U.S. provisional patent application No. 62/655,855 entitled "placement and manufacture of temporarily flexible implantable rod" filed on 2018, 4, 11, incorporated herein by reference in its entirety.
Background
Professional surgical screw-based rod instruments (i.e., pedicle screws) are surgically implanted medical devices that include, but are not limited to, special screws that are commonly used in spinal surgery to stabilize spinal segments. Such intervention is typically performed to produce spinal stability for preserving neuronal function, reducing pain, correcting deformities, and the like. In conventional spinal instrumentation, the screw and rod structure is made up of a number of components, typically including a screw head, a closure cap, a screw shaft, and a spinal rod, which is used to connect two or more screws together in a segmental or non-segmental sequence.
The metal alloy composition of the spinal rod is typically stainless steel, titanium, cobalt chromium, or others, although other less rigid compositions have been developed. The internal anatomy and pathophysiology vary widely, and no two individuals requiring surgery have a consistent spinal alignment. Additionally, intentional correction of undesirable spinal alignments requires the development of individualized rod-type structures. Real-time adjustment of the implanted metallic element is required during additional surgery to connect the structure with a previously implanted structure. Finally, the rod arrangement can also be modified based on the surgical technique and the comfort of the surgeon.
Thus, during surgery, the spinal rod must be adjusted and bent from a predetermined straight or nearly straight shape to form a suitable curvature to engage the screw structure (i.e., pedicle screw) that has been placed, which also corresponds to the desired relatively concavo-convex arrangement of the spinal column. This procedure requires either a conventional manual rod or repositioning of the implant screws, which is labor intensive and presents psychological difficulties in bending the spinal rod. Attempts to reproduce the three-dimensional contours required for implantation are done in a separate environment (on the patient or on the operating room table). This is labor intensive and can also add significant surgical time. This process requires a significant number of trial and error trials before the curvature of the spinal rod matches the internal or desired internal alignment. It is noted that similar procedures may be required in many other surgical specialties, for which spinal fixation is specifically addressed.
Technical Field
The present invention relates generally to spinal fixation devices for internal fixation of the spine, particularly in the fields of neurosurgery and orthopaedics, as well as in other fields related to spinal alignment procedures and spinal implants, including pedicle screws, lateral mass screws, anterior spinal screws, lateral spinal screws, oblique spinal screws, occiput, sacral and pelvic fixation, and spinal rods for fixing, correcting and retaining vertebrae with respect to one another.
Disclosure of Invention
Various embodiments are disclosed for forming a spinal rod member for: pedicle screws; a lateral mass screw; a trans-articular screw; a cortical screw; vertebral plate screws; facet screws; front, side and oblique screws; occiput, sacrum, and pelvic fixation screws (which will now be referred to generally as "pedicle screws") are used in spinal instrumentation, fixation procedures, and systems. A particular pedicle screw system may include a pedicle screw having a pedicle screw head and a pedicle screw shaft, the pedicle screw head configured to receive and retain a spinal rod member relative to the pedicle screw. The spinal rod member may include a predetermined rigid rod structure, an elongated tubular membrane having a flexible body, and a spinal rod body formed from a compound by inserting a liquid compound into the elongated tubular membrane and hardening the liquid compound. The pedicle screw head may include a channel or hole configured to receive and retain a spinal rod member relative to the pedicle screw and relative to the bone.
Further, a method may comprise: a first pedicle screw is attached to a first vertebra of the spine and a second pedicle screw is attached to a second vertebra of the spine, wherein the first and second pedicle screws each include a pedicle screw head and a pedicle screw shaft. The pedicle screw head may be configured to retain the spinal rod member relative to the first and second pedicle screws. Additionally, the method may include forming the spinal rod member by: positioning a flexible elongated tubular membrane in the pedicle screw heads of the first and second pedicle screws, the flexible elongated tubular membrane will maintain an effective inner channel; inserting a liquid compound into the elongated tubular membrane; the liquid compound is hardened to form a hardened spinal rod member body. Additional embodiments may include forming a spinal rod member by positioning a multi-segmented flexible elongated rod into the pedicle screw heads of the first and second screws, which rod, upon capture within the pedicle screw heads, will become rigid as the segments collapse into a rigid configuration. Additional embodiments will include susceptible liquid, semi-solid or solid compounds yet to be developed that can be transformed into a rigid state in a manner that can be implanted for spinal instrumentation and fixation.
Drawings
Many aspects of the disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the figures, like reference numerals designate corresponding parts throughout the several views.
Fig. 1 illustrates an example of a pedicle screw having a spinal rod member according to various embodiments of the disclosure.
Fig. 2 illustrates an example of a plurality of pedicle screws having spinal rod members forming a curvature according to various embodiments of the present disclosure.
Fig. 3 shows a flow diagram illustrating an example of the formation of a spinal rod member for use with the pedicle screws of fig. 1 and 2, according to various embodiments of the disclosure.
Detailed Description
The present disclosure relates to a pedicle screw spinal rod placement system and method of making the same, the system including a temporarily flexible member. The pedicle screws outlined in the present disclosure represent a number of screw fixation techniques for fixation and stabilization of the spine, including open, percutaneous, minimally invasive, and other surgical techniques. Other similar types of screws for stabilization are also within the scope of the expression "pedicle screws" including, but not limited to: a lateral mass screw; a trans-articular screw; a cortical screw; vertebral plate screws; facet screws; front, side and oblique screws; as well as occiput, sacrum, and pelvic fixation, although the details of screw differentiation will not be discussed here.
As noted above, pedicle screws are medical implant surgical devices, including specialized screws commonly used in surgery to stabilize individual spinal column segments to establish spinal stability, correct pathological spinal alignment, achieve preservation or amelioration of neuronal or other medically dependent functions, and/or reduce or alleviate pain. In conventional screw fixation, the screw is made up of a number of basic components, which typically include, but are not limited to: screw heads, which may be in a fixed orientation with respect to multiple axial directions, closure caps or retaining structures for receiving spinal rod structures, shafts of various pitches for thread formation, and spinal rods for connecting two or more screws together in non-segmented or segmented sequences. The spinal rod feature generally represents a cylindrical shape and may be an elongate rod implant of various lengths, although other embodiments include smaller circular, steel plate type systems or other types of devices for connecting vertebral segments. Spinal rods are typically constructed of a stainless steel (including but not limited to titanium or cobalt chromium), although additional less rigid or more rigid rod components are sometimes employed.
Historically, some systems for spinal fixation have been referred to as Harrington rods (Harrington rod). Strictly speaking, during surgery, the spinal rod must be adjusted and bent from a predetermined straight or nearly straight shape to form the appropriate curvature for engagement with the screw structure (i.e., pedicle screw) already placed, which also corresponds to the larger relief arrangement required for the spinal column. Such alignment may be determined to maintain the currently determined alignment based on the patient's pathophysiology or to correct the alignment using subsequent fixation for healing to achieve the desired imaging and clinical results.
Traditionally, the spinal rod adjustment procedure requires manual manipulation of the rod or repositioning of the implanted screw. It is psychologically difficult to manually adjust and bend spinal rods to reproduce the three-dimensional contours required for the endoprosthesis because the process of manual bending is traditionally done in a separate environment (on the patient or on the operating room table) and is labor intensive. In situ spinal rod bending is also difficult and potentially dangerous because of the large amount of force required to access the surgical site. Bending the spinal rod significantly increases the procedure time. This procedure requires a significant number of trial and error trials before the curvature of the spinal rod can match the implanted and desired internal anatomy. In addition, in many other surgical procedures, similar trial and error procedures may be required to implant a rigid structure to allow correction and stabilization of the physiological structure, although spinal fixation is specifically described herein.
Accordingly, various embodiments are disclosed relating to the formation of spinal rod members for use in pedicle screw systems during spinal fixation procedures. In addition, various embodiments are disclosed relating to systems that require improved techniques for adjustment and that do not require manual bending of stainless steel metal spinal rods or other components. The system may include a pedicle screw having a pedicle screw head and a pedicle screw shaft, wherein the pedicle screw head is configured to receive and retain a spinal rod member relative to the pedicle screw. Spinal rod members may include an elongated tubular membrane having a flexible body and a spinal rod body formed from a single element or compound, including but not limited to a plastic compound, a main element, a metal alloy, other compound, or other derivative, wherein the spinal rod body is formed by inserting a liquid compound into the elongated tubular membrane and allowing the liquid compound to harden.
The hardening process of the liquid compound may involve many potential methods. The method may include, but is not necessarily limited to, waiting a predetermined amount of time, applying additives that cause a chemical reaction to harden the liquid compound, photo-or electro-curing, a multi-step hardening process, selecting a metal alloy with hardening intrinsic properties, using other elements or compounds with intrinsic or adjustable properties that can be manipulated or adjusted in a controlled manner to transform from a first state that is easily moved to a more rigid state, a temperature curing method, a combination of the above methods, or other now established or future developed processes for transforming a malleable/flexible rod into a rigid structure, whether completed within a surgical wound or outside a surgical wound for implantation. The tensile and fatigue strength of spinal rods is variable and may depend on the desired stiffness of the rod based on previous surgery, surgical team expectations and long-term goals of the structure. The pedicle screw head may include a channel configured to receive and retain a spinal rod member, as may be appreciated.
Further, the method may comprise: a first pedicle screw is attached to a first vertebra of the spine and a second pedicle screw is attached to a second vertebra of the spine, wherein the first and second pedicle screws each include a pedicle screw head and a pedicle screw shaft, which may be hollow, apertured or non-apertured. The rigid or polyaxial pedicle screw head may be configured to retain the spinal rod member relative to the first and second pedicle screws. Additionally, the method may include forming the spinal rod member by positioning a flexible elongate tubular membrane in the pedicle screw heads of the first and second pedicle screws, inserting a liquid compound into the elongate tubular membrane, and hardening the liquid compound to form a hardened spinal rod member body. Additional embodiments may include forming the spinal rod member by positioning a multi-segmented flexible elongate rod to the pedicle screw heads of the first and second screws, which upon capturing the rod within the pedicle screw heads, will become rigid as the segments collapse into a rigid configuration. Additional embodiments may also include yet to be developed susceptible liquid, semi-solid or solid compounds that can be transformed into a rigid state in a manner that can be implanted for spinal instrumentation and fixation.
Turning now to fig. 1, fig. 1 illustrates a non-limiting example of a pedicle screw 100 and a spinal rod member 110 according to various embodiments. The pedicle screws 100 and spinal rod members 110 may be used as components in spinal rod-type spinal fixation systems or assemblies, as will be appreciated.
More specifically, the pedicle screw 100, similar screw implant, or other similar device may be applied to attach or secure a portion of a spinal rod member 110 or similar rod-like structure, a coating system, or other similar system associated with a vertebra or vertebral component of the spine, whether secured to the skull base, sacrum, and/or pelvis (not shown). More specifically, the pedicle screw 100 is configured to be attached to a vertebra in a manner known to a surgeon or other medical practitioner skilled in the art, while the pedicle screw head 120 of the pedicle screw 100 includes a pedicle screw hole 125, the pedicle screw hole 125 receiving, securing, retaining and supporting a portion of the spinal rod member 110 therein. It is to be understood that the vertebrae can comprise vertebrae of a mammal (e.g., a human, dog, cat, horse, or other mammal). In some embodiments, the pedicle screw head 120 may be moved and repositioned relative to the pedicle screw 100.
Further, in some embodiments, the pedicle screw head 120 includes a linking element 130, the linking element 130 being removable and attachable to the pedicle screw head 120, for example, to capture and retain a spinal rod member 110 or similar rod-type structure, coating system, or other structure on the pedicle screw 100. The pedicle screw head 120 may be attached to a pedicle screw shaft 140. the pedicle screw shaft 140 may include a threaded element (i.e., a male threaded element) for insertion into a bone, such as an anatomical location of a vertebra or other spinal segment of the spine or other suitable bony structure.
As mentioned above, conventional spinal rod implants or Harrington rods, including screws, rods, hooks, and connectors, are constructed of stainless steel or other types of metals or high tensile strength materials. The implant structure test includes the fatigue strength of the structure as a function of time. Thus, during surgery, the spinal rod must be adjusted and bent from a predetermined straight or nearly straight shape to form the appropriate curvature to engage the screw structure (e.g., pedicle screw) already placed, which also corresponds to the more concavo-convex arrangement desired for the spinal column.
The alignment may be determined to maintain a desired alignment based on the pathophysiological condition of the patient or may be corrected with subsequent fixation for healing to achieve desired imaging and clinical results. This typically requires bending a particular rod in multiple three-dimensional directions for proper implantation. Traditionally, the spinal rod adjustment procedure requires manual manipulation of the rod, or repositioning of the implanted screw. It is psychologically difficult to manually adjust and bend spinal rods to reproduce the three-dimensional contours required for the endoprosthesis because this process of manual bending is traditionally done in a separate environment (on the patient or on the operating room's table) and is labor intensive. Bending the spinal rod significantly increases the procedure time. This procedure requires a large number of trial and error until the three-dimensional curvature of the spinal rod can match the implanted and desired internal anatomy. Thus, according to various embodiments of the present disclosure, spinal rod member 110 may be formed without having to bend stainless steel or other materials, such as during surgery of the spine or other parts of the body.
In various embodiments, the spinal rod member 110 may include an elongated tubular membrane 150 having a flexible body. In some embodiments, the elongate tubular member 150 may be formed of plastic, other semi-solid, malleable solid, or other suitable material. For example, the flexible body may be used to position the elongated tubular membrane 150 in the screw head hole 125 (or other receptacle of the channel) of the one or more screw heads 120. In some embodiments, a linking element 130 or other functionally similar linking element may be used to secure the elongate tubular membrane 150 to the pedicle screw 100 after the elongate tubular member 150 is positioned in the channel 160. In some embodiments, the elongated tubular membrane 150 may include a hollow interior 170. As such, the elongated tubular member 150 may be formed of a material that provides some structural resistance when the linking element 130 is attached such that the body of the spinal rod member 110 to be formed has a substantial uniformity or homogeneity, i.e., all portions of the spinal rod member 110 are not statistically and/or functionally significantly different in cross-section. As shown in fig. 2, the spinal rod member 110 may include a substantially straight or curvilinear shape.
In one embodiment, the hollow interior 170 of the elongated tubular membrane 150 may be filled by inserting a compound 180, such as a liquid or semi-solid compound, as shown in fig. 2, to form a spinal rod body 190 when the compound has precipitated and hardened. The method used for hardening may be one of many different controlled properties of the starting compound, or activation of the liquid or semi-solid compound by any of a number of external factors. The present description does not limit the scope of potential external factors. Further, as shown in fig. 2, the elongated tubular member 150 is shown in the channel 160 of the plurality of pedicle screws 100a … … 100c, wherein the pedicle screws 100a … … 100c include pedicle screw heads 120a … … 120c and pedicle screw shafts 140a … … 140c, as shown in fig. 1. Referring again to fig. 2, in some embodiments, the compound comprises Polymethylmethacrylate (PMMA) or other suitable compounds. Additional embodiments will include susceptible liquids, semi-solids, solid compounds, or combinations thereof yet to be developed that can be converted to a rigid state in a manner that can be implanted for the purposes of spinal instrumentation and fixation.
In another embodiment, the elongated spinal rod body 110 may represent a multi-segmented flexible elongated rod to be positioned in the channel 160 of a plurality of pedicle screws 100a … … 100c, wherein the pedicle screws 100a … … 100c include pedicle screw heads 120a … … 120c and pedicle screw shafts 140a … … 140 c. After the rod is captured within the pedicle screw head 160 by the screw cap 130, the multi-segmented flexible rod will become rigid due to the process of collapsing the segments into a rigid configuration.
In any spinal construct, the number of segments to which the pedicle screw 100 is secured in a single procedure is limited only by the surgical plan of the professional surgeon and the anatomy of the patient. All of the embodiments described in detail herein can be used to secure any number of vertebral segments, including to the skull, sacrum, and pelvis.
Referring now to fig. 3, a flow diagram 300 is shown as an example of forming a spinal rod member 110 for use with one or more pedicle screws 100. Beginning at step 303, the method may include attaching a first pedicle screw 100a to a first vertebra of a spine (not shown). Next, at step 306, the method may include attaching a second pedicle screw 100b to a second vertebra of the spine (not shown). As can be appreciated, the first pedicle screw 100a and the second pedicle screw 100b may each include a pedicle screw head 120 and a pedicle screw shaft 140. Additionally, the pedicle screw heads 120 of the first and second pedicle screws 100a, 100b may be configured to retain the spinal rod member 110 relative to the first and second pedicle screws 100a, 100 b. In a similar manner, pedicle screw 100b may be configured to retain spinal rod member 110 relative to third pedicle screw 100c, which third pedicle screw 100c will continue to retain spinal rod member 110 relative to pedicle screw 100 d.
Next, with respect to steps 309-318, spinal rod member 110 may be formed. For example, with respect to step 309, the flexible elongate tubular membrane 150 may be positioned into the pedicle screw heads 120 of the first and second pedicle screws 100a, 100b (or other pedicle screws 100 as desired). Next, in step 312, a compound 180, such as a liquid, semi-solid, or flexible solid compound configured to harden over time, may be inserted into the elongated tubular film 150. In step 315, for example, the compound 180 may be hardened to form a hardened spinal rod member body. At step 315, in some embodiments, a change in temperature, light, or electricity that assists or effects hardening of the compound 180 may be applied. In step 318, the tubular membrane 150 may optionally be removed, although in some embodiments, it is understood that the tubular membrane 150 may remain intact. Thereafter, the process may continue to completion.
Unless expressly stated otherwise, alternative language such as, for example, at least one of the phrases "X, Y, or Z … …" should be understood in conjunction with the context, and is generally used to indicate that an item, term, etc. can be X, Y or Z, or any combination thereof (e.g., X, Y and/or Z). Thus, such alternative language is not generally used for and should not imply that certain embodiments require the presence of at least one X, at least one Y, or at least one Z.
It should be emphasized that the above-described embodiments of the present disclosure are merely possible examples of implementations set forth for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described embodiments without departing substantially from the spirit and principles of the invention. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims and terms.
Clause 1: a system comprising a pedicle screw and a spinal rod member, the pedicle screw comprising: pedicle screw heads; a pedicle screw shaft for implanting a pedicle screw into a vertebra of a mammalian body; and a pedicle screw hole configured to receive and retain a spinal rod member relative to the pedicle screw; the spinal rod member includes: an elongated tubular membrane having a flexible body; and a spinal rod body formed within the flexible body by hardening of the compound, wherein the spinal rod body is formed by inserting a liquid, semi-solid, or flexible compound into the flexible body and converting into a solid.
Clause 2: the article of claim 1, wherein the hardening of the compound is performed by applying at least one of: changing a temperature of the compound, applying light to the compound, applying electricity to the compound, and applying a hardener on the compound.
Clause 3: the system of any of clauses 1-2, wherein the compound comprises Polymethylmethacrylate (PMMA).
Clause 4: the system of any of clauses 1-3, wherein the elongate tubular membrane has a cross-section substantially similar to a cross-section of the screw head hole that receives and retains the spinal rod member.
Clause 5: the system of any of clauses 1-4, wherein the spinal rod member has a substantially straight or curvilinear shape.
Clause 6: a method comprising providing a pedicle screw and a spinal rod member, wherein the pedicle screw comprises: pedicle screw heads; a pedicle screw shaft for implanting the pedicle screw into a vertebra of a mammalian body; and a pedicle screw hole configured to receive and retain the spinal rod member relative to the pedicle screw; the spinal rod member includes: an elongated tubular membrane having a flexible body; and a spinal rod formed within the flexible body by hardening of the compound, wherein the spinal rod is formed by inserting a liquid, semi-solid, or flexible compound into the flexible body and converting to a solid.
Clause 7: the method of clause 6, wherein the compound comprises Polymethylmethacrylate (PMMA).
Clause 8: the method of any of clauses 6-7, wherein the elongated tubular membrane has a cross-section substantially similar to a cross-section of the screw head hole that receives and retains the spinal rod member.
Clause 9: the method of any one of claims 6-9, wherein the spinal rod member has a substantially straight or curvilinear shape.
Clause 10: the method of any of clauses 6-10, further comprising: attaching the pedicle screw to a first vertebra of the spine, the pedicle screw being a first pedicle screw; attaching second pedicle screws to second vertebrae of the spine, each second pedicle including a second pedicle screw head and a second pedicle screw shaft, the second pedicle screws including second holes configured to retain a spinal rod member relative to the first and second pedicle screws; and forming the spinal rod member by: positioning a flexible elongated tubular membrane in pedicle screw heads of the first and second pedicle screws; inserting a liquid compound into the elongated tubular membrane; and performing hardening of the liquid compound to form a hardened spinal rod member body.
Clause 11: the method of any of clauses 6-10, wherein the hardening of the compound is performed by applying at least one of: changing a temperature of the compound, applying light to the compound, applying electricity to the compound, and applying a hardener on the compound.
Clause 12: a method, comprising: attaching a first pedicle screw to a first vertebra of a spine; attaching a second pedicle screw to a second vertebra of the spine, the first and second pedicle screws each including a pedicle screw head and a pedicle screw shaft, the pedicle screw head configured to retain a spinal rod member relative to the first and second pedicle screws; forming the spinal rod member by: positioning a flexible elongated tubular membrane in pedicle screw heads of the first and second pedicle screws; inserting a liquid compound into the elongated tubular membrane; and hardening the liquid compound to form a hardened spinal rod member body, wherein hardening of the compound is performed by applying at least one of: changing a temperature of the compound, applying light to the compound, applying electricity to the compound, and applying a hardener on the compound.
Clause 13: the method of clause 12, wherein the compound comprises Polymethylmethacrylate (PMMA).
Clause 14: the method of any of clauses 12-13, wherein the elongated tubular membrane has a cross-section substantially similar to a cross-section of the channel configured to receive and retain the pedicle screw heads of the first and second pedicle screws of the spinal rod member.
Clause 15: the method of any of clauses 12-14, wherein the spinal rod member may represent a multi-segmented flexible rod that becomes rigid as a result of the compression process.
Claims (15)
1. A system, comprising:
a pedicle screw, comprising:
pedicle screw heads;
a pedicle screw shaft for implanting the pedicle screw into a vertebra of a mammalian body; and
a pedicle screw hole configured to receive and retain the spinal rod member relative to the pedicle screw; and
the spinal rod member, wherein the spinal rod member comprises:
an elongated tubular membrane having a flexible body; and
a spinal rod formed within the flexible body by hardening of a compound, wherein the spinal rod is formed by inserting a liquid, semi-solid, or flexible compound into the flexible body and converting to a solid.
2. The system of claim 1, wherein hardening of the compound is performed by applying at least one of: changing a temperature of the compound, applying light to the compound, applying electricity to the compound, and applying a hardener on the compound.
3. The system of claim 1, wherein the compound comprises Polymethylmethacrylate (PMMA).
4. The system of claim 1, wherein a cross-section of the elongated tubular membrane is substantially similar to a cross-section of the screw head hole that receives and retains the spinal rod member.
5. The system of claim 1, wherein the spinal rod member has a substantially straight or curvilinear shape.
6. A method, comprising:
providing a pedicle screw, wherein the pedicle screw comprises:
pedicle screw heads;
a pedicle screw shaft for implanting the pedicle screw into a vertebra of a mammalian body; and
a pedicle screw hole configured to receive and retain the spinal rod member relative to the pedicle screw;
providing the spinal rod member, wherein the spinal rod member comprises:
an elongated tubular membrane having a flexible body; and
a spinal rod formed within the flexible body by hardening of a compound, wherein the spinal rod is formed by inserting a liquid, semi-solid, or flexible compound into the flexible body and converting to a solid.
7. The method of claim 6, wherein the compound comprises Polymethylmethacrylate (PMMA).
8. The method of claim 6, wherein a cross-section of the elongated tubular membrane is substantially similar to a cross-section of the screw head hole that receives and retains the spinal rod member.
9. The method of claim 6, wherein the spinal rod member has a substantially straight or curvilinear shape.
10. The method of claim 6, further comprising:
attaching the pedicle screw to a first vertebra of the spine, the pedicle screw being a first pedicle screw;
attaching second pedicle screws to second vertebrae of the spine, each of the second pedicles including a second pedicle screw head and a second pedicle screw shaft, the second pedicle screws including second holes configured to retain spinal rod members relative to the first and second pedicle screws; and
forming the spinal rod member by:
positioning a flexible elongated tubular membrane in pedicle screw heads of the first and second pedicle screws;
inserting a liquid compound into the elongated tubular membrane; and
hardening of the liquid compound is performed to form a hardened spinal rod member body.
11. The method of claim 10, wherein the hardening of the liquid compound is performed by applying at least one of: changing a temperature of the compound, applying light to the compound, applying electricity to the compound, and applying a hardener on the compound.
12. A method, comprising:
attaching a first pedicle screw to a first vertebra of a spine;
attaching a second pedicle screw to a second vertebra of the spine, the first and second pedicle screws each including a pedicle screw head and a pedicle screw shaft, the pedicle screw head configured to retain a spinal rod member relative to the first and second pedicle screws;
forming the spinal rod member by:
positioning a flexible elongated tubular membrane in pedicle screw heads of the first and second pedicle screws;
inserting a liquid compound into the elongated tubular membrane; and
hardening the liquid compound to form a hardened spinal rod member body, wherein hardening of the liquid compound is performed by applying at least one of: changing a temperature of the compound, applying light to the compound, applying electricity to the compound, and applying a hardener on the compound.
13. The method of claim 12, wherein the compound comprises Polymethylmethacrylate (PMMA).
14. The method of claim 12, wherein the elongated tubular membrane has a cross-section substantially similar to a cross-section of a channel of a pedicle screw head of the first and second pedicle screws, the channel configured to receive and retain the spinal rod member.
15. The method of claim 12, wherein the spinal rod member can represent a multi-segmented flexible rod that is made rigid by a compression process.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862655855P | 2018-04-11 | 2018-04-11 | |
| US62/655,855 | 2018-04-11 | ||
| PCT/US2019/026951 WO2019200071A1 (en) | 2018-04-11 | 2019-04-11 | Temporarily flexible implantable rod placement and fabrication |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112292089A true CN112292089A (en) | 2021-01-29 |
Family
ID=68162968
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201980035135.2A Pending CN112292089A (en) | 2018-04-11 | 2019-04-11 | Placement and manufacture of temporarily flexible implantable rods |
Country Status (4)
| Country | Link |
|---|---|
| US (2) | US11413071B2 (en) |
| CN (1) | CN112292089A (en) |
| CA (1) | CA3096464A1 (en) |
| WO (1) | WO2019200071A1 (en) |
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| EP1841375A1 (en) | 2005-01-26 | 2007-10-10 | AESCULAP AG & Co. KG | Self-contouring spinal rod |
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| US20080125777A1 (en) * | 2006-11-27 | 2008-05-29 | Warsaw Orthopedic, Inc. | Vertebral Stabilizer Having Adjustable Rigidity |
| US7842040B2 (en) * | 2008-01-18 | 2010-11-30 | Illuminoss Medical, Inc. | Internal bone fixation system with integrated mixer |
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2019
- 2019-04-11 US US17/046,093 patent/US11413071B2/en active Active
- 2019-04-11 WO PCT/US2019/026951 patent/WO2019200071A1/en active Search and Examination
- 2019-04-11 CA CA3096464A patent/CA3096464A1/en active Pending
- 2019-04-11 CN CN201980035135.2A patent/CN112292089A/en active Pending
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- 2022-08-15 US US17/819,823 patent/US20220387079A1/en active Pending
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| US5658286A (en) * | 1996-02-05 | 1997-08-19 | Sava; Garard A. | Fabrication of implantable bone fixation elements |
| US20110230915A1 (en) * | 2002-03-19 | 2011-09-22 | Anderson D Greg | Device and Method for Expanding the Spinal Canal With Spinal Column Stabilization and Spinal Deformity Correction |
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Also Published As
| Publication number | Publication date |
|---|---|
| CA3096464A1 (en) | 2019-10-17 |
| US11413071B2 (en) | 2022-08-16 |
| WO2019200071A1 (en) | 2019-10-17 |
| US20220387079A1 (en) | 2022-12-08 |
| EP3773276A1 (en) | 2021-02-17 |
| US20210030444A1 (en) | 2021-02-04 |
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